Schlafender Hase

Schlafender Hase is thrilled to sponsor this RAPS Western Canada Chapter inclusive gathering for the local regulatory community. Join us to connect with fellow regulatory professionals and share the latest industry insights. Registration information below 👇

Structured content is a vital asset in the highly regulated pharma industry. It's not just about compliance—it's about ensuring patient safety and enhancing efficiency. Here, Mike Baird explores the significance of the FDA’s Structured Product Labeling (SPL) and Canada’s Structured Product Monograph (SPM). Discover how these formats promote safety and streamline processes. ✅ Learn how structured content ensures compliance. ✅ Understand the role of SPL and SPM in regulatory frameworks. ✅ Gain insights into best practices for implementation. Hit the link in the comment section.

Schlafender Hase is proud to sponsor this upcoming RAPS Western Canada Chapter in-person event, where top regulatory leaders in the Canadian #MedTech ecosystem will come together! Don’t miss this unique opportunity to hear from the experts. They’ll be discussing the importance of recognized standards, FDA’s ASCA program, and providing essential updates on upcoming regulations. Register Here: https://lnkd.in/gfvxUxbv #regulatoryaffairs #medicaldevices

We are thrilled to be exhibiting at the Regulatory Affairs Professionals Society (RAPS) Convergence next week! Join us at 822! Our team, André Cerbe, Frank G. Heßler, Peter Muller, Vineed Ravindranath & Mike Baird can't wait to connect with you. See you there! 👋

Attention Regulatory Affairs Professionals! Sponsored content from Schlafender Hase: Is improving your proofreading process still one of your goals for 2024? Join our 6-Week Pharma Proofreading Email Series. Each week, you'll receive valuable insights, practical tips and expert advice to help you spend less time reviewing documents while ensuring both compliance and accuracy for your documents and artwork. 🔍 What You'll Learn: • Best practices for error-proof labels • How to manage common proofreading challenges • Tips for maintaining document consistency • Actionable advice for recall prevention Subscribe Now: https://bit.ly/3yFpX2o #RegulatoryAffairs #Proofreading #ProfessionalDevelopment #ContentReview #ContinuousLearning

Implementing structured content isn't just a trend; it's a necessity for streamlined, compliant, and efficient product labeling. Here’s a quick guide to best practices: - Understand Regulations Start by familiarizing yourself with relevant labeling and packaging regulations. For example, in the US, SPL guidelines are crucial. Assess your current practices for any gaps or risks. - Plan Your System Requirements Choose systems with interoperability in mind. Integration, like using TVT document comparison software, can automate proofreading and ensure seamless information exchange. Don’t forget scalability and certified sources (e.g., ISO 9001:2015). - Define Your Content Structure Structure is key! Define templates, modules, and content elements (e.g., dosage, contraindications). Ensure content is centrally stored, compliant, and retrievable, covering all formats: text, images, diagrams, and more. - Develop Efficient SOPs Without SOPs, structured content can quickly fall apart. Create clear procedures for updating, reviewing, and documenting information. Define ownership and responsibility to maintain accuracy and quality. - Document and Train Keep documentation current and invest in training to ensure your team uses the system effectively. - Automate and Integrate Minimize manual tasks by automating where possible. For instance, automated proofreading can save time, reduce risk, and cut costs. Implementing these best practices will set you on the path to more efficient and compliant product labeling. Get the full picture at the link in the comment section.

We're Hiring: Software Developer C++ (m/f/d) in Frankfurt! 👩💻 Are you an experienced C++ developer ready to take on exciting challenges? We're looking for a talented Software Developer to join our team in Frankfurt. If you're passionate about object-oriented programming and eager to work with the latest advancements in C++, this could be the perfect role for you! Apply here:

Case Study Spotlight: Compliance through watertight version control at Avalis Publishing 👇 As Avalis Publishing's portfolio continues to grow, the need for efficiency and precision in document management is more critical than ever. With the implementation of TVT, the document comparison software, Avalis has not only saved valuable time but also gained the capacity to manage higher workloads and focus on other crucial tasks. Manual processes often leave room for doubt, especially when it comes to document versioning. As Alison Moraska from Avalis Publishing explains, "After running a comparison, I immediately know the extent of changes in an update, how much work will be involved, and the best path forward—whether it’s replacing a few pages or republishing an entire document." Read their case study at the link in the comment section.

We're Hiring: Inside Sales Manager (m/f/d) in Frankfurt! 🚀 Are you passionate about sales and looking to make an impact in a dynamic environment? We’re on the hunt for an Inside Sales Manager to join our team! Apply now:

Adapting to Heightened Regulatory Demands in Medical Devices 🌍 The medical device industry is facing unprecedented scrutiny. In a recent MedTech Intelligence article, Mike Baird and Peter Muller discuss how the market is evolving to meet these new challenges. With regulatory demands on the rise, companies must stay ahead by embracing innovation and refining their compliance strategies. The article highlights how organizations are not just surviving but thriving by transforming challenges into opportunities. Read more here: https://lnkd.in/eu-QHYFK Rich West Rick Biros #medtech